Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

Exclusion Criteria

• •1. Uncontrolled comorbid conditions.
• •2. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks prior to enrollment.
• •3. History or current evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.
• •4. Use of systemic immunosuppressive medications within 14 days prior to the first dose.
• •5. Clinically significant pulmonary comorbidities.
• •6. Allogeneic organ transplantation or hematopoietic stem cell transplantation (except corneal transplant).
• •7. Known hypersensitivity to bevacizumab, disitamab vedotin, or any of their components or excipients.
• •8. Spinal cord compression or clinically active central nervous system (CNS) metastases.
• •9. Unresolved toxicities or complications from prior therapy that have not recovered to baseline or ≤Grade 1 (per CTCAE v5.0).
• •10. Known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive).
• •11. Untreated active hepatitis B infection.
• •12. Active hepatitis C virus (HCV) infection.
• •13. Receipt of a live vaccine within 30 days before Cycle 1 Day 1.
• •14. Pregnant or breastfeeding women.
• •15. Any severe or uncontrolled systemic disease judged by the investigator to interfere with study participation or safety evaluation.
• •16. Gastrointestinal perforation or fistula, wound dehiscence requiring medical intervention, wound-healing complications, severe hemorrhage, arterial thrombotic events, or life-threatening (Grade 4) venous thromboembolism, including pulmonary embolism.